An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS-986165 in Participants With Normal Hepatic Function and Participants With Mild, Moderate and Severe Hepatic Impairment

The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Liver Dysfunction
• Intervention / Treatment: Drug: BMS-986165

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Praha 7, Czechia, 170 00
    • Pharmaceutical Research Associates CZ, s.r.o
• Hungary
  • Debrecen, Hungary, 4043
    • Kenézy Gyula Kórház És Rendelőintézet
  • Miskolc, Hungary, 3529
    • Clinical Research Unit Hungary
• Slovakia
  • Bratislava, Slovakia, 831 01
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
• Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.73 m2 for participants

Exclusion Criteria:

• Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant
• History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening
• Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal liver function; Single dose	Drug: BMS-986165; Oral administration
Experimental: Mild liver impairment; Single dose	Drug: BMS-986165; Oral administration
Experimental: Moderate liver impairment; Single dose	Drug: BMS-986165; Oral administration
Experimental: Severe liver impairment; Single dose	Drug: BMS-986165; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Approximately 9 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]	Approximately 9 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Approximately 9 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation	Approximately 44 days
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations	Approximately 44 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; BMS-986165
• Other Study ID Numbers: IM011-062; 2018-002534-20 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes